The purpose of this study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Also, to monitor muscle strength, balance/gait and blood flow in the lower extremity before and after surgery.

Further study details as provided by Foot Surgery Center of Northern Colorado:

Primary Outcome Measures:

EMG signals used intraoperative as objective measurements before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery [ Time Frame: Within one month of surgical date, surgical date, 3 months and 6 months post operative ] [ Designated as safety issue: No ]

Primary Endpoint is assessed by changes in:

Neuromotor function in the lower limb as measured by intraoperative electromyographic(EMG) recordings of the muscles in the anterior and lateral compartments of the leg and muscles of the foot.

Blood flow in the lower limb both distal to and proximal to the nerve release sites, as measured by duplex doppler of the external femoral artery (a.), superficial femoral a., popliteal a., anterior and posterior tibial a., dorsal pedis a. Shear stress changes in these arteries.

Lower limb performance defined as:

Dorsiflexor strength and speed of contraction

Proprioception at the ankle

One-legged standing balance

Functional reach

Sensory function in the foot

Usual gait speed

Standardized tests of mobility

Secondary Outcome Measures:

Improvement in sensory perception [ Time Frame: up to one month of surgical date, 3 months and 6 months post operative ] [ Designated as safety issue: No ]

Two-point discrimination

Changes in nerve conduction measures

Changes in ankle-brachial index (ABI)

Visual Analog Score (VAS) for neuropathic symptoms

Estimated Enrollment:

40

Study Start Date:

November 2012

Estimated Study Completion Date:

July 2014

Estimated Primary Completion Date:

January 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Procedure: Arm A - Non-Diabetic, Gait and Balance

Arm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University.

Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet.

Detailed Description:

Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb.

Participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint;

Women considering pregnancy or are pregnant.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735903